FDA Issues Nyxoah an Approvable Letter for its Genio® System
Nyxoah (NYXH) has received an Approvable Letter from the FDA for its Genio® system, a neuromodulation device treating Obstructive Sleep Apnea (OSA). The letter indicates that Nyxoah's Pre-Market Approval (PMA) application substantially meets federal requirements, with final approval pending completion of manufacturing facilities, methods and controls review.
The FDA's review found no additional questions regarding clinical data or biocompatibility supporting the submission. The Genio system maintains its CE Mark and continues commercial operations in Europe, where it's approved for both Complete Concentric Collapse (CCC) and non-CCC patients.
Nyxoah (NYXH) ha ricevuto una Lettera di Approvazione dall'FDA per il suo Genio® system, un dispositivo di neuromodulazione che tratta l'Apnea Ostruttiva del Sonno (OSA). La lettera indica che la domanda di Approvazione Pre-Mercato (PMA) di Nyxoah soddisfa sostanzialmente i requisiti federali, con l'approvazione finale in attesa del completamento della revisione delle strutture di produzione, dei metodi e dei controlli.
La revisione dell'FDA non ha sollevato ulteriori domande riguardo ai dati clinici o alla biocompatibilità a supporto della presentazione. Il sistema Genio mantiene il suo Marchio CE e continua le operazioni commerciali in Europa, dove è approvato sia per i pazienti con Collasso Concentrico Completo (CCC) che per quelli non-CCC.
Nyxoah (NYXH) ha recibido una Carta Aprobable de la FDA para su sistema Genio®, un dispositivo de neuromodulación que trata la Apnea Obstructiva del Sueño (OSA). La carta indica que la solicitud de Aprobación Pre-Mercado (PMA) de Nyxoah cumple sustancialmente con los requisitos federales, con la aprobación final pendiente de la finalización de la revisión de las instalaciones de fabricación, métodos y controles.
La revisión de la FDA no encontró preguntas adicionales sobre los datos clínicos o la biocompatibilidad que respaldan la presentación. El sistema Genio mantiene su Marca CE y continúa las operaciones comerciales en Europa, donde está aprobado tanto para pacientes con Colapso Concéntrico Completo (CCC) como para aquellos no-CCC.
Nyxoah (NYXH)는 FDA로부터 Genio® 시스템에 대한 승인 가능 통지를 받았습니다. 이는 폐쇄성 수면 무호흡증(OSA)을 치료하는 신경 조절 장치입니다. 이 통지는 Nyxoah의 사전 시장 승인(PMA) 신청이 연방 요구 사항을 상당히 충족한다고 알려주며, 최종 승인은 제조 시설, 방법 및 관리 검토 완료 후에 이루어질 예정입니다.
FDA의 검토에서는 제출을 지원하는 임상 데이터나 생체 적합성에 대한 추가 질문이 없었습니다. Genio 시스템은 CE 마크를 유지하며, CCC(완전 동심 붕괴) 및 비-CCC 환자 모두에 대해 승인된 유럽에서 상업적 운영을 계속하고 있습니다.
Nyxoah (NYXH) a reçu une Lettre d'Approbation de la FDA pour son système Genio®, un dispositif de neuromodulation traitant l'Apnée Obstructive du Sommeil (OSA). La lettre indique que la demande d'Approbation Préalable au Marché (PMA) de Nyxoah répond substantiellement aux exigences fédérales, l'approbation finale étant en attente de l'achèvement de l'examen des installations de fabrication, des méthodes et des contrôles.
La révision de la FDA n'a trouvé aucune question supplémentaire concernant les données cliniques ou la biocompatibilité soutenant la soumission. Le système Genio conserve son Marquage CE et continue ses opérations commerciales en Europe, où il est approuvé tant pour les patients avec Collapsus Concentrique Complet (CCC) que pour les patients non-CCC.
Nyxoah (NYXH) hat ein Genehmigungsschreiben von der FDA für sein Genio®-System erhalten, ein Neuromodulationsgerät zur Behandlung der obstruktiven Schlafapnoe (OSA). Das Schreiben zeigt an, dass der Antrag auf Vorabgenehmigung (PMA) von Nyxoah die bundesstaatlichen Anforderungen im Wesentlichen erfüllt, wobei die endgültige Genehmigung von der Fertigstellung der Überprüfung der Produktionsstätten, Methoden und Kontrollen abhängt.
Die Überprüfung der FDA ergab keine weiteren Fragen zu klinischen Daten oder zur Biokompatibilität, die die Einreichung unterstützen. Das Genio-System behält sein CE-Zeichen und setzt die kommerziellen Aktivitäten in Europa fort, wo es sowohl für Patienten mit vollständigem konzentrischen Kollaps (CCC) als auch für Nicht-CCC-Patienten zugelassen ist.
- FDA Approvable Letter received, indicating substantial compliance with requirements
- No additional clinical data or biocompatibility questions from FDA
- Continued European commercialization unaffected
- CE Mark approval maintained for both CCC and non-CCC patients
- Final FDA approval still pending manufacturing facilities review
- Additional regulatory requirements must be met before US market entry
INSIDE INFORMATION
REGULATED INFORMATION
FDA Issues Nyxoah an Approvable Letter for its Genio® System
Mont-Saint-Guibert, Belgium – March 26, 2025, 8:00am CET / 3:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the U.S. Food and Drug Administration (FDA) has issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio® system.
The Approvable Letter means that Nyxoah’s application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA’s PMA implementing regulations codified at 21 C.F.R. Part 814, and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review. The Company will work closely with the FDA to address these requests and is committed to bringing this innovative therapy to U.S. patients.
“The FDA has reviewed our submission and determined that it substantially meets the requirements for approval: the FDA’s Approvable Letter included no further questions on the clinical data or biocompatibility that support the submission,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “We are still on the right track to make Genio available to U.S. patients suffering from OSA.”
This decision does not impact Genio's CE Mark or ongoing commercial activities in Europe, where the device is approved for both Complete Concentric Collapse (CCC) and non-CCC patients.
About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.
Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study.
For more information, please visit http://www.nyxoah.com/.
Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.
FORWARD-LOOKING STATEMENTS
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; the satisfactory completion of a manufacturing facilities, methods and controls review and receipt of FDA approval; entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
Contacts:
Nyxoah
John Landry, CFO
IR@nyxoah.com
For Media
In United States
FINN Partners – Alyssa Paldo
alyssa.paldo@finnpartners.com
In International/Germany
MC Services – Anne Hennecke
nyxoah@mc-services.eu
In Belgium/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be
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FAQ
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